CDC Offers New Guidelines for Antiretroviral Treatment Following HIV Exposure

Action Points

For persons seeking care less than 72 hours after non-occupational exposure to blood, genital secretions, or other potentially infectious body fluids of a person known to be HIV infected, when that exposure represents a substantial risk for transmission, a 28-day course of highly active antiretroviral therapy (HAART) is recommended. Antiretroviral medications should be initiated as soon as possible after exposure.

Advise patients that the new guidelines generally do not recommend an antiretroviral regimen for persons with exposure histories that represent no substantial risk for HIV transmission or when a patient visits a doctor more than 72 hours after possible exposure. The therapy also is not recommended for patients who consistently put themselves at risk of contracting HIV.

Many European nations along with Australia and Brazil have long had policies recommending that a regimen of retroviral drugs be administered to rape victims. However, the official US policy formulated in the 1990s recommended that only health-care workers accidentally exposed to HIV in the course of their jobs receive anti-retroviral therapy.

Some healthcare practitioners called this CDC policy "unconscionable," according to the Associated Press. California Assemblyman Paul Koretz, quoted in the article, said that as a result of it, "thousands of unnecessary HIV infections may have occurred."

Previously, Mr. Koretz had sponsored a bill in California to make anti-retrovirals available to expanded groups immediately after their possible exposure to HIV. States such as New York, Massachusetts, and Rhode Island, meanwhile, devised guidelines of their own, making retroviral therapy available to victims of sexual assault, the AP said.

Thus, the new guidelines, announced January 20, 2005, represent a significant policy shift for the agency. In issuing them, a high-ranking CDC official noted that the drugs are not to be construed as "a substitute for abstinence, mutual monogamy, or consistent and correct condom use, and should not be viewed as a quick fix."

The new guidelines resulted from studies showing that post-exposure prophylaxis may prevent transmission of HIV. the CDC statement said.

The most direct evidence supporting the efficacy of post-exposure prophylaxis is a case-control study of needlestick injuries to healthcare workers. In this study, the prompt initiation of zidovudine was associated with an 81% decrease in the risk for acquiring HIV.

Although analogous clinical studies of non-occupational post-exposure prophylaxis (nPEP) have not been conducted, data are available from observational studies and registries.

Among the new guidelines:

Non-occupational post-exposure prophylaxis should be administered to patients who seek it within 72 hours of high-risk exposure "with a person known to be HIV-infected."

Non-occupational post-exposure prophylaxis is not recommended when a patient seeks care more than 72 hours following an occurrence in which there is a low risk of exposure.

In cases in which the risk of exposure is high but the patient seeks care more than 72 hours after exposure, physicians "might consider prescribing nPEP & if, in their judgment, the diminished potential benefit of nPEP outweighs the risks for transmission and adverse events."

Evaluate treatment on a case-by-case basis when patients consult with a physician within 72 hours of possible exposure and don't know the HIV status of the person who may have exposed them to the disease.

Initiate treatment as quickly as possible following exposure and continue the therapy for 28 days.

The guidelines call for the use of "Any three-drug combination of antiretroviral medications recommended by the U.S. Department of Health and Human Services except those containing nevirapine," which has been linked to liver damage and other possible severe reactions when administered under conditions similar to non-occupational post-exposure prophylaxis. "Women of childbearing age or who are pregnant should not be administered a regimen that includes the drug efavirenz, due to a possible increased risk of birth defects."

Reviewed by Zalman S. Agus, MD Emeritus Professor at the University of Pennsylvania School of Medicine

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